rituximab in treating patients with refractory or relapsed primary cns lymphoma

Conditions: Lymphoma

Summary: rationale: monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. purpose: phase ii trial to study the effectiveness of rituximab in treating patients who have refractory or relapsed primary cns lymphoma.

objectives: primary * determine the radiographic response proportion in patients with refractory or recurrent primary cns lymphoma treated with rituximab. secondary * determine the progression-free and overall survival of patients treated with this drug. * determine the toxicity profile of this drug in these patients. outline: this is a multicenter study. patients receive rituximab iv on days 1, 8, 15, and 22. treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. patients may receive additional courses of rituximab off study at the discretion of the treating physician. patients are followed every 2 months. projected accrual: a total of 15-25 patients will be accrued for this study within 5-9 months.

Eligibility criteria:
disease characteristics: * histologically confirmed primary cns lymphoma based on 1 of the following: * histologically confirmed non-hodgkin's b-cell lymphoma by brain biopsy or resection * positive cerebrospinal fluid (csf) cytology or immunohistochemical diagnosis of csf monoclonality with or without measurable intracranial disease * histologically confirmed vitreal lymphoma with measurable intracranial tumor * cd20 positive by brain biopsy * measurable (greater than 1 cm in diameter) tumor by ct scan or mri * progressed during first-line chemotherapy and/or radiotherapy or relapsed after initial successful treatment * no systemic lymphoma by ct scan of the chest, abdomen, and pelvis with contrast * no leptomeningeal lymphoma by lumbar puncture for cns cytology/flow cytometry * no ocular lymphoma by slit lamp examination patient characteristics: age * 18 and over performance status * karnofsky 60-100% life expectancy * not specified hematopoietic * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 * hemoglobin at least 9.0 g/dl hepatic * bilirubin less than 1.5 mg/dl * transaminases less than 4 times upper limit of normal renal * creatinine less than 1.5 mg/dl other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for 1 year after study participation * hiv negative * mini mental status examination score at least 15 * no concurrent serious infection * no other medical illness that would preclude study treatment * no other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ prior concurrent therapy: biologic therapy * more than 90 days since prior biologic therapy * no prior rituximab * no concurrent prophylactic growth factors (e.g., filgrastim \[g-csf\] or sargramostim \[gm-csf\]) chemotherapy * see disease characteristics * at least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) endocrine therapy * not specified radiotherapy * see disease characteristics * at least 3 months since prior radiotherapy surgery * not specified other * recovered from prior therapy * more than 90 days since prior investigational drugs * more than 90 days since prior use of a therapeutic device

Keywords: primary central nervous system non-hodgkin lymphoma